18 and older, any sex, with HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Quality of PrEP Counseling Provided by Health Care Workers Delivering PrEP to Adolescent Girls and Young Women for HIV Prevention in KenyaPrimary· Unannounced standardized patient actor visits take approximately 15 minutes each, taking place over 3-4 months.
Quality is assessed as total score from a checklist provided by the SPs after each unannounced visit (n=71 SP visits in each arm) including domains of communication skills and adherence to national guidelines. Communication quality is assessed in an adapted version of the Bayer-Fetzer Kalamazoo Consensus Statement; scores range from 7-28 with higher scores indicating higher quality communication. Guideline adherence is assessed in a scoring system adapted from the Kenyan National AIDS \& STI Control Programme guidelines; scores range from 0-13 with higher scores indicating higher PrEP competen
Overall quality
Group
Value
95% CI
Training Intervention
73.6
± 16.3
Standard of Care Control
58.4
± 16.7
Guideline adherence
Group
Value
95% CI
Training Intervention
57.2
± 25.4
Standard of Care Control
36.2
± 26.9
Communication skills
Group
Value
95% CI
Training Intervention
90.0
± 10.9
Standard of Care Control
80.5
± 11.4
Competency Score Measuring Quality of PrEP Counseling Provided by Health Care Workers During Clinical Training Intervention [Among Intervention Arm Only]Secondary· Standardized patient actor training interactions take approximately 15 minutes each and will occur during a two-day training intervention. Trainings will be conducted over a period of 2-3 months.
The secondary outcome is PrEP competency among HCWs in interactions with SPs during the clinical training intervention, assessed as sub-scores for interpersonal skills, communication quality, and guideline adherence. Interpersonal skills are assessed using the Interpersonal skills (IPS) assessment tool (Van Zanten 2007); scores range from 1-16 with higher scores indicating better interpersonal skills. Communication quality is assessed in an adapted version of the Bayer-Fetzer Kalamazoo Consensus Statement; scores range from 7-28 with higher scores indicating higher quality communication. Guide
Overall quality (sum of adherence and communication)
Group
Value
95% CI
Training Intervention
83.1
± 10.1
Guideline adherence
Group
Value
95% CI
Training Intervention
66.1
± 20.7
Communication skills
Group
Value
95% CI
Training Intervention
96.2
± 8.1
Interpersonal skills
Group
Value
95% CI
Training Intervention
86.9
± 8.7
Sponsor's own description
The goal of this study is to facilitate uptake of and adherence to HIV pre-exposure prophylaxis (PrEP) among adolescent girls and young women (AGYW) in Kenya. The investigators will conduct a cluster randomized controlled trial at 24 health facilities in Kisumu, Kenya of a clinical training intervention using standardized patient actors. The hypothesis is that the training will improve quality of PrEP service delivery, defined as adherence to national guidelines and non-judgmental communication.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02928900 — Patient Actor Training to Improve HIV Services for Adolescents in Kenya
· NA
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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Sponsor: as reported to ClinicalTrials.gov by University of Washington
Last refreshed: 12 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03875950.